3. Draft Requirements for Good Manufacturing Practice in the Manufacture and Quality Control of Drugs and Pharmaceutical Specialities EB 41/38, 11, 01.(1968).

4. WHO Technical Report Series 418 Annex 2. Genf (1969)

5. Good Practice in the Manufacture and Quality Control of Drugs and Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, Official Records of the World Health Organisation No.226 Twenty Eighth World Health Assembly Geneva, 13-30 May 1975 Annex 12 pps 88-96 (1975)

6. Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products, European Yearbook volume XVIII 1970 729-747

H. Kőszeginé Szalai, T. Kósa: Regulation of the manufacture and wholesale distribution of medicines in the European Union and in Hungary

In the introductory part of the paper history of the supervision of drug manufacture including the implementation of GMP rules is Hungary is presented by the authors. In the further chapters the legal tools and the system of guidelines regulating the manufacture , importation and wholesale distribution of medicines as well as the manufacture, importation and distribution of active substances and excipients thereof in the EU are shown. This is followed by the discussion of the content of the law and other regulation including the role and responsibilities of the actors participating in the supply chain and of the supervisory authorities in ensuring the GMP/GDP compliance of the manufacture and distribution of medicines and their ingredients. The rules relating to the manufacturers and distributors acting within or outside the EU are equally covered, with reference to the respective paragraphs of the EU law and guidelines. The authors also outline the current forms of cooperation within the network of the European national supervisory authorities and the European Medicines Agency in building and maintaining an effective system of GMP/GDP compliance monitoring as well as the new tendencies in the GMP/GDP regulation in the EU and worldwide.

Détári G.:Quality Management System at manufacturer and distributor of Active Pharmaceutical Substances

Each manufacturer and distributor should maintain an effective Quality System to ensure the high quality of Active Substance, using for medicinal product. In the article the main element of Quality System is discussed e.g. Training of personnel, release system, documentation system, how to handles deviations or change control, emphasis the importance of process validation and internal audit as well

The aim of the article is to give some ideas for auditors for performing an effective audit at Active Substances manufacturer.

The article considers the European requirement for distribution of these types of products; give some idea on the principles of good distribution practices for active substances for medicinal products for human use

The goal of the present experiment was to track the decay of cytostatic pollution in Budapest’s MHEK. The initial levels were ascertained during a 2013 national audit, and we accelerated the rate of decay using a series of decontamination measures during 2015. Such measures included the drafting of more effective cleaning protocols, implementing stricter security proceedings, and transitioning to the Tevadaptor closed system in the production of mixed infusions.

Our experience shows that a combination of good workflow management and the adaptation of closed systems pushes the levels of contamination below the threshold of detection.

We believe the main value of our experiment is that it proved in a methodologically sound manner that contamination can be reduced radically. However, we must also point out that the present experiment was limited in scope to the hospital’s pharmacy. If the hospital is to combat pollution effectively, they should also frequently re-evaluate other protocols, such as those applying to the nurses.